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Efficacy of a Brief Intervention on Reduction of Systolic Blood Pressure

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ClinicalTrials.gov Identifier: NCT03077373
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : March 11, 2019
Sponsor:
Collaborator:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Information provided by (Responsible Party):
University Medicine Greifswald

Brief Summary:
This study examines the efficacy of individualized counseling letters to reduce systolic blood pressure level of ≥ 130 mmHg in individuals aged between 40 and 65 years. The computer-generated counseling letter intervention aimed to increase moderate-to-vigorous physical activity, to reduce sedentary time, and to achieve smoking abstinence.

Condition or disease Intervention/treatment Phase
Blood Pressure, High Cardiovascular Risk Factor Behavioral: Counseling letter Not Applicable

Detailed Description:

This study examines the efficacy of individualized counseling letters to reduce systolic blood pressure level of ≥ 130 mmHg in individuals aged between 40 and 65 years. The computer-generated counseling letter intervention aimed to increase moderate-to-vigorous physical activity, to reduce sedentary time, and to achieve smoking abstinence. Participants are recruited by nurses in routine care of primary medical practices.

Informed consent consists of: (i) participation in standardized measurement of blood pressure as well as waist and hip circumference at baseline and 12-month follow up, (ii) completion of standardized questionnaires at 4 time points (baseline, 4-month, 7-month, and 12-month follow-up). Participation in accelerometry was defined as an option. Individuals who agree to wear the accelerometer do this for 10 days at baseline and 12-month follow-up, each.

After baseline assessment, individuals are randomly allocated to a control and to an intervention group (ratio 1:1).

Intervention: The computerized intervention system includes three interactions with participants aiming to increase moderate-to-vigorous physical activity and to reduce sedentary time. For individuals who were daily smokers at baseline, the computerized intervention system includes three more interactions with participants aiming to foster the motivation to quit smoking. Recurrent assessments are initiated by the system and provide data for scheduling the proceeding intervention steps and selection of relevant content. Physical activity, sedentary time, smoking, and motivational measures to change or maintain behaviors according to the recommendations will be monitored over time and used to provide feedback in the form of letters.

Intervention group: Individuals in this group complete a tablet PC-supported assessment at baseline and 12-month follow-up, both at the general practice. At months 4 and 7, follow-up data are collected by study team members via phone call. According to the assessments (baseline, month 4, and month 7), participants receive three counseling letters aiming to increase moderate-to-vigorous physical activity and to reduce sedentary time. Additionally, individuals who were daily smokers at baseline, receive three counseling letters aiming to foster the motivation to quit smoking. The first letter is accompanied by a self-help manual covering specific information relevant for the particular stage of motivation to change smoking behavior according to the principles of the Transtheoretical Model of behavior change.

Control group: Individuals in this group complete a tablet PC-supported assessment at baseline and 12-month follow-up, both in the general practice. At months 4 and 7, follow-up data are collected by study team members via phone call.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Efficacy of a Computerized Brief Intervention Targeting Physical Activity, Sedentary Behavior, and Smoking Cessation on the Reduction of Systolic Blood Pressure in Individuals Aged 40 to 65 Years
Actual Study Start Date : January 16, 2017
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Counseling letter (intervention group)
Intervention group: Individuals in this group complete a tablet PC-supported assessment at baseline and 12-month follow-up, both at the general practice. At months 4 and 7, follow-up data are collected by study team members via phone call. According to the assessments (baseline, month 4, and month 7), participants receive three counseling letters aiming to increase moderate-to-vigorous physical activity and to reduce sedentary time. Additionally, individuals who were daily smokers at baseline, receive three counseling letters aiming to foster the motivation to quit smoking. The first letter is accompanied by a self-help manual covering specific information relevant for the particular stage of motivation to change smoking behavior.
Behavioral: Counseling letter

The brief counseling letter intervention aiming to reduce physical inactivity, sedentary time in leisure time as well as smoking is based on behavior change theories (Transtheoretical model of health behavior change and Health Action Process Approach).

The computerized intervention system includes up to six interactions with participants. Recurrent assessments are initiated by the system and provide data for scheduling the proceeding intervention steps and selection of relevant content. Physical activity, sedentary time, smoking, and motivational measures to change or maintain behaviors according to the recommendations will be monitored over time and used to provide feedback in the form of letters.


No Intervention: No counseling letter (control group)
Control group: Individuals in this group complete a tablet PC-supported assessment at baseline and 12-month follow-up, both in the general practice. At months 4 and 7, follow-up data are collected by study team members via phone call.



Primary Outcome Measures :
  1. Systolic blood pressure [ Time Frame: Change from baseline mean systolic blood pressure at 12 months ]
    Reduction of 4 mmHg mean systolic blood pressure in intervention group; Measures: standardized measurements of mean systolic blood pressure (in mmHg)


Secondary Outcome Measures :
  1. Waist and hip circumference [ Time Frame: Change from baseline waist and hip circumference at 12 months ]
    Reduction of waist and hip circumference in intervention group; Measures: standardized measurements of waist and hip circumference (in cm)

  2. Physical activity by self-report [ Time Frame: Change from baseline physical activity at 12 months ]
    Measures: assessement via tablet PC or phone calls (International Physical Activity Questionnaire, IPAQ)

  3. Physical activity by accelerometry (if data are available) [ Time Frame: Change from baseline physical activity at 12 months ]
    Measures: objective measurement of physical activity by accelerometry

  4. Sedentary time by self-report [ Time Frame: Change from baseline sedentary time at 12 months ]
    Measures: assessement via tablet PC or phone calls (last 7-d sedentary behavior questionnaire, SIT-Q-7d)

  5. Sedentary behavior by accelerometry (if data are available) [ Time Frame: Change from baseline physical inactivity at 12 months ]
    Measures: objective measurement of sedentary behavior by accelerometry

  6. Smoking by self-report [ Time Frame: Change from baseline smoking at 12 months ]
    Measures: questions regarding smoking (assessment via tablet PC or phone calls)



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • men and women aged between 40 and 65 years
  • mean systolic blood pressure ≥ 130 mmHg at baseline

Exclusion Criteria:

  • cardiovascular event (myocardial infarction, stroke)
  • vascular intervention
  • cognitive impairment
  • inadequate language skills
  • severe disease with reduced life expectancy (< 2 years)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077373


Locations
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Germany
Institute of Social Medicine and Prevention, University Medicine Greifswald
Greifswald, Germany, 17475
Sponsors and Collaborators
University Medicine Greifswald
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Investigators
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Study Chair: Sabina Ulbricht, Dr. Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany

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Responsible Party: University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT03077373     History of Changes
Other Study ID Numbers: BB005/17
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Medicine Greifswald:
systolic blood pressure
physical activity
sedentary time
smoking
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases